Diploma in ICH-GCP Managed Trials

Get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials

9 - 11 May 2023

or

20 - 22 Sep 2023

On location

Danish

19,550 DKK ex VAT

(app. 2,628 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this course, you get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course consists of presentations from authorities and experts in clinical trials complemented by group work and cases.

The starting point of this course is current legislation and guidelines and the different roles and responsibilities of monitors and investigators/study nurses.

Furthermore, focus is on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimise your collaboration with your partners.

To achieve a Diploma you must pass the exam, which is held approximately four weeks after the course. The exam must be purchased separately . If you do not take the exam, you will receive a certificate of completion.


This is what COURSE PARTICIPANTS SAY

"It was a very well-planned course with good lectures and course leaders who had a great overview and managed the course very well."

Pernille Videbæk Pedersen, GCP-Coordinator, Aarhus University.


"It was a very well-structured course, which academically had a high level." 

Pernille Skovby, National Coordinator at DanPedMed.


Keywords

  • Good Clinical Practice ICH-GCP
  • National legislation
  • Audit and inspection
  • Essential documents
  • Safety reporting
  • Site management from site and sponsor’s/CRO’s perspective

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Course leader(s) & Lecturer(s)

  • Birgitte Horst
    Course leader
    Auditor, GCP-koordinator
    GCP-Enheden
  • Lene Palfelt
    Course leader
    Competency Development Specialist
    Novo Nordisk A/S
  • Charlotte Calov
    Lecturer
    Head of the GCP Unit at Odense University Hospital
    GCP-enheden ved Odense Universitetshospital
  • Mia Bekker Leimand
    Lecturer
    Databeskyttelsesrådgiver
    Region Syddanmark
  • Lene Grejs Petersen
    Lecturer
    Chefkonsulent
    Lægemiddelstyrelsen
  • Eva Gjerlevsen Harreskov
    Lecturer
    Project Data Manager
    Novo Nordisk A/S
  • Heidi Filtenborg Madsen
    Lecturer
    Senior Specialist, QPPV Office
    Lundbeck A/S
  • Amalie Engemand Henriksen
    Lecturer
    Associate Director, Global Clinical Drug Supply
    Genmab
  • Lene Eskildsen
    Lecturer
    Head of Quality Assurance
    Vicore Pharma AB
  • Pernille Ask Aabo
    Lecturer
    GCP Koordinator; M.Sc.Pharm
    GCP-enheden
  • Solveig Nordahl Jacobsen
    Lecturer
    Akademisk medarbejder, cand.pharm
    National Videnskabsetisk Komité
  • Birgitte Claudius
    Lecturer
    Sr. Medical Director
    Astellas Pharma A/S
  • Malene Hansen
    Lecturer
    RBQM Specialist
    Novo Nordisk A/S
See all

IS THIS COURSE FOR YOU?

This diploma course is a basic training aimed at new monitors, project nurses, and investigators. It is an advantage to have some experience in the field.

What you will learn

  1. How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
  2. What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
  3. How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
  4. How to collect, monitor and file clinical trial related data throughout the clinical trial
  5. The importance of timely and accurate management of safety data
  6. The importance of correct handling of study medication from packaging to destruction

What your company will get

  1. A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
  2. A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
  3. A GCP professional who knows the principles and practical aspects of effective site monitoring
  4. An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
  5. An employee who understands the responsibilities and duties of both investigator and sponsor

Course calendar

Choose your starting date
Starting 9 May 2023
Starting 20 Sep 2023
9 May 2023 10:00-17:25

DAY 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
10 May 2023 8:30-17:40

DAY 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
11 May 2023 8:30-15:25

DAY 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

1 Jun 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
2 May 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
9 - 11 May
20 Sep 2023 10:00-17:25

DAY 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
21 Sep 2023 8:30-17:40

DAY 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
22 Sep 2023 8:30-15:25

DAY 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

27 Oct 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
13 Sep 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
20 - 22 Sep
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus.

Prerequisites

Experience with contractual relations in clinical trials is an advantage, but not a requirement.

Examination

The exam  is held online, usually 4-6 weeks after the course.

You will receive a link with exam questions via your personal Atrium log-in.

In order to participate in the exam, you must have attended the course.

Course leader(s)

Birgitte Horst
Auditor, GCP-koordinator
GCP-Enheden
Lene Palfelt
Competency Development Specialist
Novo Nordisk A/S

Lecturer(s)

Charlotte Calov
Head of the GCP Unit at Odense University Hospital
GCP-enheden ved Odense Universitetshospital
Mia Bekker Leimand
Databeskyttelsesrådgiver
Region Syddanmark
Lene Grejs Petersen
Chefkonsulent
Lægemiddelstyrelsen
Eva Gjerlevsen Harreskov
Project Data Manager
Novo Nordisk A/S
Heidi Filtenborg Madsen
Senior Specialist, QPPV Office
Lundbeck A/S
Amalie Engemand Henriksen
Associate Director, Global Clinical Drug Supply
Genmab
Lene Eskildsen
Head of Quality Assurance
Vicore Pharma AB
Pernille Ask Aabo
GCP Koordinator; M.Sc.Pharm
GCP-enheden
Solveig Nordahl Jacobsen
Akademisk medarbejder, cand.pharm
National Videnskabsetisk Komité
Birgitte Claudius
Sr. Medical Director
Astellas Pharma A/S
Malene Hansen
RBQM Specialist
Novo Nordisk A/S
Birgitte Horst
Auditor, GCP-koordinator
GCP-Enheden
Lene Palfelt
Competency Development Specialist
Novo Nordisk A/S

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WANT TO KNOW MORE or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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